The number of people diagnosed with gall stones is increasing all around the world. Every year, one million more Americans are diagnosed with gallstones, joining the 20 million others who already have the condition. This condition is treated by performing a cholecystectomy which involves the surgical removal of the patient's gallbladder. Commonly, the procedure is performed laparoscopically. Approximately 1.2 million laparoscopic procedures are carried out in the U.S. per year with mortality rate ranging from 0.22% to 0.4%. Sometimes the procedure leads to morbidity such as trocar/Veress needle injury, hemorrhage, post-cholecystectomy syndrome, common bile duct (CBD) injury or stricture, wound infection or abscess, ileus, gallstone spillage, and deep vein thrombosis. Such morbidity could be reduced by performing an endoscopic cholecystogastrostomy, cholecystoduodenostomy or a cholecystojejunostomy procedure allowing for drainage of the gallbladder and also for removal of the gallstones.
A pancreatic pseudocyst is a serious complication of pancreatitis and results in collection of fluid around the pancreas. The fluid in the cyst is usually pancreatic juice that has leaked out of a damaged pancreatic duct. Pancreatic pseudocysts arise after acute pancreatitis or chronic pancreatitis. In some patients, the pseudocyst may develop soon after an attack of acute pancreatitis. Often the patient can present many weeks or months after recovery from an attack of acute or chronic pancreatitis. The common symptoms that patients present are pain in the abdomen, a feeling of bloating, poor digestion of food, or complications related to the pseudocyst such as infection of the pseudocyst with a pancreatic abscess, bleeding into the pseudocyst, or blockage of parts of the intestine by the pseudocyst.
Usually, such morbidity is treatable by the laparoscopic or endoscopic formation of an anastomosis bypass which facilitates trans-gastric or trans-duodenal endoscopic drainage of symptomatic pancreatic pseudocysts greater than 6 cm in size, with greater than 70% fluid content that are adherent to the gastric or bowel wall. There are other multiple benign and malignant indications, such as cancer obstruction as well as the treatment of gastroparesis, diabetes and obesity, where gastro-enteric or entero-enteric anastomosis are desired. Most of these anastomoses are performed surgically.
Prior art devices for creating anastomoses often comprise a piercing tip which can be hazardous and cause injury to adjacent organs. The instruments often use a grasping mechanism which may be difficult to maneuver. Further, two punctures are required for the operation of some prior art instruments, which may increase the chance of leak from the puncture site from the grasper. Also, certain prior art devices are only able to appose the adjacent walls without enough pressure to damage and necrose the intervening tissue to thereby create a large enough anastomosis that will remain open for long durations to provide adequate drainage. Additional interventions would be needed to create a large opening. While stents made of materials such as a shape memory alloy (SMA), which are endoscopically inserted into a human body for creating an anastomosis and draining a pancreatic pseudocyst, are known, using these devices requires multiple interventions for the placement and removal of the stent and dealing with frequent clogging from debris in the pancreatic fluid.
In addition, prior art magnetic anastomosis methods typically require the use of two separate mating devices deployed individually in two adjacent organs. A first device is delivered to the lumen of a first organ and a second device is delivered to a lumen of a second organ. Magnetic forces pull the two devices together, capturing and compressing portions of the walls of the two organs between the devices, eventually leading to tissue necrosis and anastomosis formation. The devices usually have a single loop polygon shape deployment configuration, with no out-of-plane bending. The devices often include additional features to assist in creating the desired deployment shape, such as an exoskeleton and guide and opening/closing elements.
Hence, what is needed is an efficient and small anastomosis device which may be easily delivered within a human body without the need for graspers. What is also needed is an anastomosis device which may be deployed by a single operator using single endoscopic procedure making a single puncture in an organ wall to deliver the entire device. It is also desirable to have a piercing mechanism separate from the anastomosis device and which is not left in the body with the anastomosis device, decreasing the possibility of injury to internal organs. Further, there is need for an anastomosis device which exerts a sufficiently high enough compressive force on organ walls to create an anastomosis between the organs, yet remains a small enough profile to be delivered through an endoscope or laparoscopic or other minimally invasive tools. There is also a need for an anastomotic device that does not rely solely on the magnetic forces for correct orientation and positioning inside the human body and does not require the accurate manual positioning of two separate compressive elements. There is also a need for an anastomosis device that can connect two hollow organs without the need to advance an endoscope or laparoscope into both the organs and the device can be placed by endoscopically or laparoscopically accessing a first of the two organs while the second organ is accessed by the device delivery catheter.